Compositions and methods

Abstract

Disclosed herein are therapeutic compositions containing non-pathogenic, germination-competent bacterial spores, for the prevention, control, and treatment of gastrointestinal diseases, disorders and conditions and for general nutritional health.

What is claimed is: 
     
       1. A therapeutic composition formulated for oral administration comprising a purified population of bacteria, an enteric coating, and a capsule, wherein the purified population of bacteria consist of spore-forming bacteria, and wherein at least one of the spore-forming bacteria are selected from the group consisting of  Clostridium methylpentosum, Clostridium  sp YIT 12069 , Anaerofustis stercorihominis, Bacteroides galacturonicus, Bacteroides pectinophilus, Brachyspira pilosicoli, Clostridium beijerinckii, Clostridium carnis, Clostridium favososporum, Clostridium  sp. L2-50,  Clostridium  sp. MT4 E,  Clostridium  sp. NML 04A032 , Clostridium  sp. SS211 , Clostridium stercorarium, Clostridium xylanolyticum, Coprococcus  sp. ART55/1 , Deferribacteres  sp. oral clone JV006 , Desuljitobacterium frappieri, Exiguobacterium acetylicum, Lachnospira multipara , and  Lachnospira pectinoschiza.    
     
     
       2. The composition of  claim 1 , wherein the spore-forming bacteria consists essentially of germinable bacterial spores. 
     
     
       3. The composition of  claim 1 , wherein the composition is derived from a fecal material subjected to ethanol treatment or heat treatment. 
     
     
       4. The composition of  claim 3 , wherein the composition is derived from fecal material subjected to ethanol treatment. 
     
     
       5. The composition of  claim 4 , wherein the composition is derived from fecal material subjected to treatment with 30-90% ethanol. 
     
     
       6. The composition of  claim 4 , wherein the composition is derived from fecal material subjected to treatment with 50-70% ethanol. 
     
     
       7. The composition of  claim 4 , wherein the composition is derived from fecal material subjected to treatment with 50% ethanol. 
     
     
       8. The composition of  claim 4 , wherein the composition augments a titer of one or more non-pathogenic  Bacteroides  selected from the group consisting of  Bacteroides  sp. 4_1_36 , Bacteroides cellulosilyticus, Bacteroides  sp. 1_1_30 , Bacteroides  uniformis,  Bacteroides ovatus, Bacteroides dorei, Bacteroides xylanisolvens , and  Bacteroides  sp. 3_1_19; and
 wherein the non-pathogenic  Bacteroides  titer is augmented in the gastrointestinal tract of the subject. 
 
     
     
       9. The composition of  claim 3 , wherein the fecal material is a 10 to 20% fecal suspension. 
     
     
       10. The composition of  claim 3 , wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a pathogen or a pathobiont prior to production of the fecal material. 
     
     
       11. The composition of  claim 3 , wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a blood-borne pathogen or a fecal bacterial pathogen prior to production of the fecal material. 
     
     
       12. The composition of  claim 1 , wherein the composition comprises at least 10×10 4  colony forming units of the spore-forming bacteria per dose of the composition. 
     
     
       13. The composition of  claim 1 , wherein the capsule is a delayed release capsule. 
     
     
       14. The composition of  claim 1 , wherein the purified population of bacteria are substantially free of residual habitat products. 
     
     
       15. The composition of  claim 14 , wherein the residual habitat product is an abiotic material, a human or animal cell, a virus, a fungus, a  mycoplasma , a  toxoplasma , an eukaryotic parasite, or a combination thereof. 
     
     
       16. The composition of  claim 1 , wherein the composition further comprises an excipient. 
     
     
       17. The composition of  claim 16 , wherein the excipient is a germinant. 
     
     
       18. The composition of  claim 1 , wherein the purified population of bacteria are lyophilized.